(RTTNews) -  Tuesday, medical device and cardiovascular tissue processing company CryoLife Inc. (CRY: News ), said the U.S. Food and Drug Administration has approved the conduct of human clinical trials using its BioFoam technology, for sealing liver tissue during excessive bleeding. The company will now seek approval from the U.S. Department of Defense for the final go-ahead with the trials.

The FDA approval is for a prospective, multi-center, randomized feasibility study evaluating safety outcomes of CryoLife's Investigational Device Exemption or IDE, BioFoam Surgical Matrix protein hydrogel technology, as compared to a standard topical hemostatic agent.

BioFoam will be used in 20 eligible subjects in two centers, to help seal liver parenchymal tissue, where ligature or other conventional methods are ineffective or impractical in preventing excessive bleeding.

Steven Anderson, president and chief executive officer said "Following our July 2009 CE Mark approval to distribute BioFoam in the EU, we now have approval to begin a clinical trial, a critical step forward in the process to gain FDA approval of BioFoam in the U.S.".
The company is currently conducting a 60-patient controlled clinical launch of BioFoam at up to six centers in the United Kingdom, Germany, France and Italy, and estimates the annual European market opportunity for BioFoam to be approximately $30 million and more than $100 million worldwide.

Following the successful completion of the feasibility study, given FDA and DoD approvals, CryoLife plans to follow-on using a pivotal study with 164 eligible subjects with a primary objective to show decrease in the time to stop bleeding, following open liver resection surgery, compared with standards.

CRY stock gained 2.89% or 20 cents when it last traded at $7.13 on the New York Stock Exchange on Tuesday.

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by RTT Staff Writer

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